GENEVA, October 13, 2010 /PRNewswire/ -- Merck Serono, a
division of Merck KGaA, Darmstadt, Germany, announced today that the new
Cyanokit(R) 5 g presentation (hydroxocobalamin) has been approved
by the European Commission. Cyanokit(R) is currently available in a
kit comprising two 2.5 g vials as the starting dose that totals 5 g
hydroxocobalamin. The new presentation contains the starting dose
of 5 g hydroxocobalamin in a single vial.
Cyanokit(R) is indicated for the treatment of known or suspected
cyanide poisoning. The drug is typically administered by fire and
rescue crews at an emergency scene or in a hospital emergency room.
It must be administered in conjunction with appropriate
decontamination and supportive measures.
"Immediate administration of an emergency treatment on the scene
of a fire within the first minutes after rescue is critical for the
survival of a smoke inhalation victim," said Dr. Bernhard Kirschbaum, Executive Vice President
Research and Development at Merck Serono. "By simplifying the
reconstitution and administration processes, we believe that the
new Cyanokit 5 g presentation represents a major improvement,
allowing for rapid management of cyanide poisoning, a vital asset
particularly when treating more than one victim."
Cyanide poisoning commonly results from exposure to smoke
produced from burning synthetic substances or natural materials
such as cotton or paper in a closed environment. Additional causes
may include accidental or intentional ingestion, exposure during
industrial accidents, or a terrorist attack involving cyanide.
In Europe, Cyanokit(R) is
marketed by Merck Serono, with the exception of the Netherlands, Ireland, the United
Kingdom and the Nordic and Baltic countries where it is
marketed by its partner Swedish Orphan Biovitrum.
In the US, a Supplemental New Drug Application (sNDA) for the
new Cyanokit(R) presentation is currently under review by the Food
and Drug Administration (FDA).
About Cyanokit(R)
The active ingredient in Cyanokit(R), hydroxocobalamin, is a
precursor of vitamin B12. Hydroxocobalamin works by binding
directly to the cyanide ions, creating cyanocobalamin, a natural
form of vitamin B12, which is excreted in the urine.
Advantages of this approach are that methemoglobin is not
produced and the oxygen-carrying capacity of the victim's blood is
not lowered. Therefore, Cyanokit(R) is suitable for use in smoke
inhalation victims. The most common adverse reactions seen in
clinical trials of hydroxocobalamin with human subjects are
transient and include: reddish discoloration of the skin, mucous
membranes and urine, rash, increased blood pressure, nausea,
vomiting, diarrhea, headache, decreased white blood cell count and
injection site reactions. Allergic reactions have been observed.
Usage may interfere with some clinical laboratory evaluations.
The starting dose of Cyanokit(R) for adults is 5 g, administered
by intravenous infusion. Depending upon the severity of the
poisoning and the clinical response, a second dose of 5 g may be
administered up to a total dose of 10 g.
About Merck Serono
Merck Serono is the division for innovative prescription
pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical
company. Headquartered in Geneva,
Switzerland, Merck Serono discovers, develops, manufactures
and markets innovative small molecules and biopharmaceuticals to
help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately
incorporated affiliates.
Merck Serono has leading brands serving patients with cancer
(Erbitux(R), cetuximab), multiple sclerosis (Rebif(R), interferon
beta-1a), infertility (Gonal-f(R), follitropin alpha), endocrine
and metabolic disorders (Saizen(R) and Serostim(R), somatropin),
(Kuvan(R), sapropterin dihydrochloride) as well as cardiometabolic
diseases (Glucophage(R), metformin), (Concor(R), bisoprolol),
(Euthyrox(R), levothyroxine). Not all products are available in all
markets.
With an annual R&D expenditure of more than EUR 1 billion, Merck Serono is committed to
growing its business in specialist-focused therapeutic areas
including neurodegenerative diseases, oncology, fertility and
endocrinology, as well as new areas potentially arising out of
research and development in autoimmune and inflammatory
diseases.
About Merck
Merck is a global pharmaceutical and chemical company with total
revenues of EUR 7.7 billion in 2009,
a history that began in 1668, and a future shaped by approximately
40,000 (including Merck Millipore) employees in 64 countries. Its
success is characterized by innovations from entrepreneurial
employees. Merck's operating activities come under the umbrella of
Merck KGaA, in which the Merck family holds an approximately 70%
interest and free shareholders own the remaining approximately 30%.
In 1917 the U.S. subsidiary Merck & Co. was expropriated and
has been an independent company ever since.
For more information, please visit http://www.merckserono.com or
http://www.merck.de